Elliesen Jörg, Trummer Dietmar
Bayer Pharma AG, Berlin, Germany.
Int J Womens Health. 2016 Aug 9;8:351-6. doi: 10.2147/IJWH.S107516. eCollection 2016.
The Clyk™ digital pill dispenser helps ensure correct and consistent administration of a flexible extended regimen of the combined oral contraceptive, ethinylestradiol (EE) 20 μg/drospirenone 3 mg (EE/drospirenone ; YAZ(®) Flex Flex), guiding users through the intake cycle and 4-day pill break and providing visible and acoustic daily reminders when pill intake is due. A study showed that the audible alarm function of the dispenser could help reduce the number of missed pills, but it lacked an appropriate "non-dispenser" group for a meaningful assessment of the impact of the dispenser on adherence. This study indirectly assessed the overall effect of the digital dispenser on adherence by comparing data from a treatment with standard blister packaging.
One-year adherence data were compared from two similarly designed, Phase III, open-label, randomized trials of EE/drospirenoneFlex. In study 1, women used diary cards to record adherence with EE/drospirenoneFlex dispensed in blister packs (n=640), and in study 2 the dispenser was used with the alarm activated (n=250) or deactivated (n=248) in addition to using diary cards.
A mean (±SD) of 4.3 (±4.24) missed pills over 1 year were recorded in diary cards among women who dispensed their pills from the blister packages (study 1) compared with 1.0 (±2.4) recorded by the alarm-activated dispenser (study 2). In study 2, a mean of 1.9 (±4.2) missed pills were reported in the diaries over 1 year compared with 4.4 (±9.1) from automatic recording by the dispenser (both arms of study 2), indicating underreporting of missed pills in diary cards vs the digital dispenser. Adjusting for this rate of underreporting, an estimated mean of ten pills were missed over 1 year by women using EE/drospirenoneFlex in blister packs, or ten times more than with the digital dispenser with activated acoustic alarm.
The digital dispenser helps reduce the number of missed pills and increases adherence.
Clyk™数字药丸分配器有助于确保灵活延长的复方口服避孕药炔雌醇（EE）20μg/屈螺酮3mg（EE/屈螺酮；YAZ(®) Flex Flex）方案的正确和一致服用，引导使用者完成服药周期和4天的停药期，并在应服药时提供视觉和听觉每日提醒。一项研究表明，该分配器的可听警报功能有助于减少漏服药丸的数量，但缺乏一个合适的“非分配器”组来对分配器对依从性的影响进行有意义的评估。本研究通过比较标准泡罩包装治疗的数据，间接评估了数字分配器对依从性的总体影响。
比较了两项设计相似的EE/屈螺酮Flex III期开放标签随机试验的一年依从性数据。在研究1中，女性使用日记卡记录从泡罩包装中分发的EE/屈螺酮Flex的依从性（n=640），在研究2中，除使用日记卡外，分配器在警报激活（n=250）或未激活（n=248）的情况下使用。
在研究1中，从泡罩包装中取药的女性在日记卡上记录的一年中平均（±标准差）漏服4.3（±4.24）片药，而在研究2中，警报激活的分配器记录的漏服片数为1.0（±2.4）片。在研究2中，日记中记录的一年中平均漏服1.9（±4.2）片药，而分配器自动记录的漏服片数为4.4（±9.1）片（研究2的两个组），这表明日记卡上漏服药丸的报告低于数字分配器。调整漏报率后，使用泡罩包装的EE/屈螺酮Flex的女性在一年中估计平均漏服10片药，是激活声音警报的数字分配器的10倍。
数字分配器有助于减少漏服药丸的数量并提高依从性。
